Federal Register / Vol. 70, No.
58 / Monday, March 28, 2005 / Notices
formal presentations from members of
industry and FDA. Following the formal
presentations, time will be allotted to
hear from members of the public who
have pre-registered as speakers. After
the pre-registered speakers, there will be
a moderated discussion open to all
members of the audience.
FDA is considering issuing draft
guidance on this issue and believes it is
important to receive input from all
interested parties through a public
meeting.
V. Speakers
Members of the public who would
like to make a short statement
(approximately 5 minutes) should
register with DIA (see ADDRESSES) by
April 26, 2005. Requests to speak
should include the speaker’s name and
affiliation, and should identify the
appropriate panel (public health or legal
issues). DIA will notify persons who
register by April 26, 2005, of the
approximate time of their turn to speak.
Speakers will be scheduled in the order
DIA receives the requests.
If you need special accommodations
due to a disability, please contact, at
least 7 days in advance: Amanda
Carmody, Drug Information Association,
at Amanda.carmody@diahome.org or
215–442–6176.
VI. Request for Comments and
Transcripts
Regardless of attendance at the
meeting, interested persons may submit
to the Division of Dockets Management
(see ADDRESSES) written or electronic
comments on the topics presented in
this document. The agency welcomes
comments before and after the meeting.
Two paper copies of mailed comments
are to be submitted, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. Comments and
a transcript of the public meeting will
be made available on the Office of
Combination Products Web site at
www.fda.gov/oc/combination.
Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–5978 Filed 3–25–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0103]
Draft Guidance for Industry on Using a
Centralized Institutional Review
Boards Process in Multicenter Clinical
Trials; Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Using a Centralized
IRB Process in Multicenter Clinical
Trials.’’ The draft guidance is intended
to assist sponsors, institutions,
institutional review boards (IRBs), and
clinical investigators involved in
multicenter clinical research in meeting
the requirements of FDA’s regulations
by facilitating the use of a centralized
IRB review process.
DATES: Submit written or electronic
comments on the draft guidance by May
27, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Nancy Stanisic, Center for Drug
Evaluation and Research (HFD–1),
Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–1660; or
Steve Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
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20852–1448, 301–827–6210, 301–
827–7975; or
Dave Lepay, Good Clinical Practice
Program, Office of Science and
Health Coordination (HF–34),
Office of the Commissioner, 5600
Fishers Lane, Rockville, MD 20857,
301–827–3340.
SUPPLEMENTARY INFORMATION: FDA is
announcing the availability of a draft
guidance for industry entitled ‘‘Using a
Centralized IRB Review Process in
Multicenter Clinical Trials.’’ The draft
guidance is intended to assist sponsors,
institutions, IRBs, and clinical
investigators involved in multicenter
clinical research in meeting the
requirements of 21 CFR part 56 by
facilitating the use of a centralized IRB
review process. The draft guidance: (1)
Describes the roles of the participants in
a centralized IRB review process; (2)
offers guidance on how a centralized
IRB review process might address local
aspects of IRB review; (3) makes
recommendations about documenting
agreements between a central IRB and
the IRBs at institutions involved in the
centralized IRB review process
concerning their respective
responsibilities; and (4) makes
recommendations concerning written
procedures for implementing a
centralized review process. Finally, the
draft guidance discusses using a central
IRB at clinical trial sites not already
affiliated with an IRB.
This draft guidance applies to clinical
investigations conducted under 21 CFR
part 312 (investigational new drug
application or IND regulations).
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance represents
the agency’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Two
copies of any mailed comments are to be
submitted, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Dockets
Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
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 15636 Federal Register / Vol. 70, No. 58 / Monday, March 28, 2005 / Notices
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at
http://www.fda.gov/cder/guidance/
index.htm, http://www.fda.gov/cber/
guidelines.htm, or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–5977 Filed 3–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for PARAPLATIN
(carboplatin), TRUSOPT (dorzolamide),
CAMPTOSAR (irinotecan), PREVACID
(lansoprazole), TAMIFLU (oseltamivir),
VIOXX (rofecoxib), FERRLECIT (sodium
ferric gluconate), IMITREX
(sumatriptan), DETROL and DETROL
LA (tolterodine). These summaries are
being made available consistent with
the Best Pharmaceuticals for Children
Act (the BPCA). For all pediatric
supplements submitted under the
BPCA, the BPCA requires FDA to make
available to the public a summary of the
medical and clinical pharmacology
reviews of the pediatric studies
conducted for the supplement.
In addition, the agency is also
announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies for the following
antidepressants: CELAXA (citalopram),
REMERON (mirtazapine), SERZONE
(nefazodone), PAXIL (paroxetine), and
ZOLOFT (sertraline). Studies for these
drugs were submitted before the BPCA
was implemented. Therefore, they are
not subject to its requirements.
However, due to the public’s interest in
these pediatric studies, FDA asked the
sponsors to consent to the public
disclosure of a summary of the medical
and clinical pharmacology reviews for
these studies. Based on sponsors’
consent, FDA is making the summaries
publicly available.
VerDate jul<14>2003 15:12 Mar 25, 2005 Jkt 205001
ADDRESSES: Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
summaries.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research (HFD–960),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–594–7337, e-mail:
carmouzeg@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies. As discussed in greater detail in
the following paragraphs, section 9 of
the BPCA (Public Law 107–109)
requires the disclosure of certain
summaries of pediatric study reviews.
In addition, based on the sponsors’
consent, FDA is making available
summaries of medical and clinical
pharmacology reviews for pediatric
studies of antidepressants submitted in
response to a written request.
The summaries of medical and
clinical pharmacology reviews of
pediatric studies conducted for
PARAPLATIN (carboplatin), TRUSOPT
(dorzolamide), CAMPTOSAR
(irinotecan), PREVACID (lansoprazole),
TAMIFLU (oseltamivir), VIOXX
(rofecoxib), FERRLECIT (sodium ferric
gluconate), IMITREX (sumatriptan),
DETROL and DETROL LA (tolterodine)
are being made available consistent with
section 9 of the BPCA. Enacted on
January 4, 2002, the BPCA reauthorizes,
with certain important changes, the
pediatric exclusivity program described
in section 505A of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355a). Section 505A of the act
permits certain applications to obtain 6
months of marketing exclusivity if, in
accordance with the requirements of the
statute, the sponsor submits requested
information relating to the use of the
drug in the pediatric population.
One of the provisions the BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the BPCA, the BPCA requires
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FDA to make available to the public a
summary of the medical and clinical
pharmacology reviews of pediatric
studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries
are to be made available not later than
180 days after the report on the
pediatric study is submitted to FDA (21
U.S.C. 355a(m)(1)). Consistent with this
provision of the BPCA, FDA has posted
on the Internet (http://www.fda.gov/
cder/pediatric/index.htm) summaries of
medical and clinical pharmacology
reviews of pediatric studies submitted
in supplements for PARAPLATIN
(carboplatin), TRUSOPT (dorzolamide),
CAMPTOSAR (irinotecan), PREVACID
(lansoprazole), TAMIFLU (oseltamivir),
VIOXX (rofecoxib), FERRLECIT (sodium
ferric gluconate), IMITREX
(sumatriptan), DETROL and DETROL
LA (tolterodine). Copies are also
available by mail (see ADDRESSES).
In addition, the agency is also
announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies for the following
antidepressants: CELAXA (citalopram),
REMERON (mirtazapine), SERZONE
(nefazodone), PAXIL (paroxetine), and
ZOLOFT (sertraline). Section 9 of the
BPCA does not require the disclosure of
these summaries. However, due to the
public’s interest in these studies, FDA
asked the sponsors to consent to the
public disclosure of the summaries of
the medical and clinical pharmacology
reviews. Based on the sponsors’
consent, FDA is making the reviews
publicly available on the Internet
(http://www.fda.gov/cder/pediatric/
index.htm) and by mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at http://
www.fda.gov/cder/pediatric/index.htm.
Dated: March 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–5974 Filed 3–25–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
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